Innovating Patient Driven Nutritional Care Across Europe: The Optimal Nutritional Care for All (ONCA) Multi-Stakeholder Initiative

Regulatory NewsRegulatory News
| 24 October 2017 | By Frank de Man, LLM, PhDCees Smit, DrhcManfred Ruthsatz, PhD

This article addresses a European public-private healthcare initiative to implement Optimal Nutrition Care for All (ONCA) for patients. It underlines the importance of an effective multi-stakeholder approach in 16 participating countries, based on sound policymaking. A fit-for-purpose, innovation-friendly regulatory framework is required to help provide appropriate, timely, and cost-efficient healthcare solutions for increased patient access.


Disease-related malnutrition and undernutrition in patients is a significant, often still unrecognized, health issue in Europe as well as other parts of the world.1 The European Nutrition for Health Alliance (ENHA)-driven ONCA campaign is a multi-stakeholder initiative to promote the idea that "…every citizen who is malnourished or at risk of undernutrition, is systematically screened and has access to appropriate, equitable, high quality nutritional care."2, 3 Key to the ONCA campaign's effectiveness is aligning national stakeholders, such as healthcare professionals, patient groups, industry associations and public authorities, behind agreed-upon objectives. Priorities are to establish a national alliance to develop a nutritional care plan to facilitate malnutrition screening and nutritional care implementation as well as actively promote public awareness, appropriate reimbursement policies, and related medical education.

Regulatory Framework to Develop Nutrition Care Solutions

Health and disease management can benefit significantly from using all options from medicinal treatment, lifestyle changes, and nutrition. This requires a regulatory framework encouraging innovation globally in order to determine the most suitable pathways for nutrition, health, and disease management.4 Establishing a category of food for special medical purposes (FSMP),5, 6 i.e., "medical food" in the US,7 distinct from drugs, but for the specific dietary management of patients with a disease or condition, has been a global challenge over the last several decades.8  Both regulators and industry have struggled to bring innovative, safe, and cost-effective nutritional products - with evidence of clinical benefit - to patients who have an inability to maintain a normal diet. The opportunity to increase the value of this category will depend on bringing together stakeholders representing nutritional and regulatory science and medical practice, as well as healthcare funding entities and patient organizations to leverage potential clinical benefits of FSMP in the management of a range of diverse diseases and conditions.

This effort would need to be accommodated within a regulatory framework that adequately protects consumers and patients while allowing for timely scientific evaluation and progress of nutritional interventions.9 Here, regulators can learn from how the European Medicines Agency (EMA) works with patients and consumers through the Patients' and Consumers' Working Party (PCWP), which provides a platform for exchange of information and discussion of issues of common interest between EMA, patients and consumers. The PCWP, established in 2006, has enabled the agency to build upon its existing interactions with patients and consumers and provides recommendations to EMA and its human scientific committees on all matters of interest in relation to medicines.

A Multi-Stakeholder Partnership Enhancing the Voice of the Patient

"Patient Perspectives on Nutrition,"10 developed in 2013 by the European Patients' Forum (EPF), European Genetic Alliances Network (EGAN), and the European Nutrition for Health Alliance (ENHA), emphasizes nutrition as an essential part of health and disease management. It examines the role of nutrition in relation to a variety of health issues, including brain disorders, cancer, coeliac disease, diabetes, inflammatory bowel disease, kidney disease, as well as promoting nutritional care before, during and after pregnancy. It illustrates how effective healthcare requires good nutritional care by translating awareness and needs into practice, as well as the requirement to develop appropriate, performing, healthcare solutions.

Yet, awareness of nutrition and its therapeutic potential is still limited among many key healthcare stakeholders. In 2005, a group of European health and nutrition professionals gathered in Amsterdam to discuss why most health care professionals and other stakeholders in the European public health and healthcare arena have no - or limited - interest in nutrition and nutritional care.11 Obesity, clearly recognized as a form of malnutrition, is a concern and policy priority of many national governments, including the European Commission and WHO EURO. However, despite overwhelming scientific evidence, malnutrition/undernutrition, and the value of nutritional care in maintaining health and preventing disease, does not appear on health professionals' "radar screens." To help drive action for correcting this situation, a group of professional societies created the European Nutrition for Health Alliance (ENHA) in London.12 ENHA members and partners (Table 1) work together to help implement science outcomes for better nutritional care for citizens across Europe to maintain health, prevent disease, and optimize clinical outcomes for patients.

Table 1. ENHA Member Organizations

The International Association of Mutual Benefit Societies (AIM)
European Association of Homes and Services for the Ageing (EAHSA)
European Federation of the Associations of Dietitians (EFAD)
European Hospital and Healthcare Federation (HOPE)
European Nursing Directors Association (ENDA)
European Society of Clinical Nutrition and Metabolism (ESPEN)
European Union Geriatric Medicine Society (EUGMS)
International Association Geriatrics and Gerontology (IAGG)
International Longevity Centre - UK
Medical Nutrition International Industry (MNI)
Pharmaceutical Group of the European Union (PGEU)

In 2012, ENHA signed a Memorandum of Understanding (MoU) with the European Patients Forum (EPF) and Patients' Network for Medical Research and Health (EGAN).

With support  from the European Parliament and selected national initiatives since 2008, the Optimal Nutritional Care for All (ONCA) campaign started in 2013-2014. Designed to improve nutritional screening and follow-up care, decreasing malnutrition and undernutrition in the EU and WHO-EURO countries ONCA also aims to encourage implementation of national plans and best practices in each European country13 where an estimated 33 million adults in Europe are nutritionally at-risk.14

Patients with chronic diseases who suffer from undernutrition and/or disease-related malnutrition, require significantly greater resource use estimated to cost European healthcare systems as much as €170 ($200) billion each year.15 Full implementation of the ONCA campaign aims to:

  • contribute to improved health through both prevention programmes and in healthcare
  • drive public private collaboration in nutrition and health
  • help to make nutritional care an integral part of health and healthcare
  • create continuous innovation by sharing good practices among the countries

These efforts will significantly drive quality of care, improve patients' health,  and reduce cost.16, 17

An Innovation Partnership Changing Healthcare Practice Across Europe

ENHA has established successful collaborations with the European Parliament and is one of the founding organizations of the European Innovation Partnership Active and Health Ageing (EIP-AHA).18 The Action Group A3 focuses on the prevention of functional decline and frailty and brings together approximately 100 organizations, among which are public health authorities, care organizations, academia, research centers, industries, patients associations and professional bodies. These stakeholders are committed to the objectives of understanding the underlying factors of frailty, exploring the association between frailty and adverse health outcomes in older people, and improved prevention and management of the frailty syndrome and its consequences. These organizations are each implementing their own commitments, which take the form of measurable, concrete activities at local, regional or national levels. All are aiming at improving the health and quality of life of older people. The ONCA campaign is ENHA's commitment to the European Innovation Partnership.

Scientific evidence and the European policy support are key steps toward success. Yet, in European policies, public health and healthcare, there are 'subsidiary' issues where EU institutions and WHO have no, or only very limited, operational mandate. This means that member states are primarily responsible for translating better nutrition and nutritional care into daily healthcare practices. Hence, ENHA decided to engage with and support individual countries to implement the ONCA campaign nationally and translated the ENHA platform into an 'implementation engine.'

ENHA member organizations are connected with their national leaders to gauge their interest in joining a multi-country campaign and step in with their national societies and associations to establish national, multidisciplinary platforms similar to how ENHA is structured at European level. From eight countries participating in 2014, participation has now increased to 16 and additional countries have expressed interest in participating (Figure 1).

Figure 1. Sixteen ONCA Countries (2017)

Ruthsatz - Fig 1

Nutrition Care Includes "by Patients, for Patients"

Key to establishing solid commitment and leverage  by European and national stakeholders is participation of European patient organizations. In 2012, ENHA signed a Memorandum of Understanding with the European Patients Forum (EPF) and the Patients' Network for Medical Research and Health (EGAN). At the 2013 EPF conference in Dublin, a dedicated nutrition and health meeting was organized with more than 30 disease-specific European patients' organizations represented. Nutrition and health was, for the first time, featured on their shared agenda. Since then, EPF, EGAN, ENHA and the country delegations work together; patient representatives participate in the national platforms as well. At the third ONCA conference, held November 2016 in Madrid, EPF and EGAN organized a dedicated session in which parents, patients and representatives from the national Spanish patients' organization discussed patient needs in nutritional care as well as the importance of related scientific research.19, 20

Some speakers in Madrid also urged the scientific community to look beyond randomized clinical trials to assess effectiveness of new treatments, diagnoses and medical products. They strongly requested that the patient experience, also called "citizen research," be included in order to value the uniqueness of the individual and address specific individual needs.

The relevance of nutrition for patients was reemphasized at an European-wide patient groups meeting in Brussels in June 2017.21 They emphasized the need for nutrition and nutritional care for diverse patient groups, especially those with prevalent comorbidities, and the use of multiple medication (polypharmacy), which varies significantly. The effort's impact depends on the value that nutrition or nutritional care can add to the prevention, treatment, and management of the specific disease, disability and quality of life.

Patients and their families are looking for information about common - as well as personalized - food. Patient groups are demanding self-management options in nutrition and health as well as an active, supporting role by health professionals, who currently often show a lack of knowledge and/or coordination among staff. Consequently, education and training in nutritional care should be an integrated part of curricula in applied science and university programs. Also in this context, the question was posed regarding who can lead coordination when self-care is difficult or no longer possible? Access and co-ownership of one's own health data are seen as the cornerstone of empowerment and increasing adherence. Patient organizations play a key role in providing peer support, in understanding their communities, giving information "by patients, for patients," performing advocacy for patient-centred health services and policy, developing and sharing good practices, and collaborating with HCPs, academia and other vested stakeholders.

Cachexia in Cancer
Urgency and relevance of nutrition for patients were clearly demonstrated by a presentation from Isabelle Manneh from the European Cancer Patient Coalition (ECPC) during the EU Patient Group Nutrition Conference of June 2017.22 ECPC performed a study among 907 people with cancer, of which more than 90 percent did not receive any information about cachexia from their health professionals. Whereas, almost 70 percent reported that they lost weight after the cancer diagnosis. More than 70 percent of respondents did not know the meaning of the term 'cachexia.' The ECPC endorses the need to empower individual patients and patient associations by producing more information on cancer patients' nutritional needs, as well as by drafting a 'Cancer Patients Bill of Rights' for appropriate and prompt nutritional support.

At the conclusion of this important meeting, European Patient Forum chair Marco Greco announced that nutrition, nutritional care, and the collaboration with ONCA are one of EPF's key priorities for the upcoming years.23

Measuring and Sharing ONCA's Progress

Changing healthcare practices is a major challenge for any healthcare system. However, to guide and accelerate the national implementation efforts, ENHA and the country delegations developed a set of tools and templates to help. Although participation is voluntary, by sharing resources and good practices the country delegations work along the same lines, but with the liberty to diverge and choose tailored, national solutions (as in national healthcare systems) 'one size does not fit all.'

To measure progress, the ONCA Steering Committee and experts developed a 'dashboard' divided into categories with relevant indicators for national implementation of optimal nutritional screening and follow-up care for prevalence, public health awareness, policy and standards, reimbursement, education, implementation criteria, and economic data. Figure 2 provides an example dashboard from a participating country ONCA platform.

Figure 2. ONCA Dashboard - Example from a Participating Country (2016)

Ruthsatz - Fig 2

The dashboard is a self-assessment tool to be used once or twice a year for the country's platform measures of national progress and to be shared with the other countries. The agenda and yearly action plan are discussed twice a year at the ONCA workshop and implementation conference, which this year will be hosted by the Slovenian delegation in Bled in 2017.24

Conclusion: 2018 and Beyond

Future challenges will be in keeping up the pace, securing sustainability, and managing growth. Together with the ONCA member countries, ENHA is working on the 2018-2020 strategy and action plan. A key target will be to refresh and accelerate communications to better visualize and make society aware of:

  • the relevance and added value of nutrition and nutritional care for European citizens
  • the potential of combining citizen driven health and healthcare with improving quality of life and saving cost
  • the progress that is made at both country and European levels

Overall, more cost savings can be gained as well as a re-integration of people with chronic diseases in societal life when more optimal prevention programs can turn the growth of healthcare costs, now caused by too many people with lifestyle diseases need cures.

Together with latest ENHA member, the European Association for Homes and Services for the Ageing (EAHSA), the feasibility of launching a program to measure the quality of providing services and care for the aging sector is being explored, including issues of food and nutrition in healthcare institutions across Europe. Another priority for the near future is in applied research, such as measuring the cost-benefit ratio of nutritional care at the country level. National figures have been shown to have more impact on policymakers than outcomes of international studies.25

Developing nutrition therapy-based solutions requires a global, fit-for purpose, regulatory framework for providing appropriate, timely, and cost-efficient healthcare solutions for an increased patient access.26,27 It is essential to reduce development disincentives, such as unnecessary technological restrictions, and include patient perspectives and needs while formulating products based on sound medical and nutritional principles (e.g., ESPEN Guidelines; EFSA Guidance) to meet their intended use for the dietary management of diseases, disorders or medical conditions.28, 29

Innovation in public health and healthcare takes time. However, with the joint commitment of patients' groups and a wealth of professionals in 16 countries to work together on achieving the ONCA objectives, progress can be made one patient at a time.30


  1. Medical Nutrition International Industry (MNI) - Oral Nutritional Supplements to Tackle Malnutrition. A Summary of the Evidence Base. 3rd edition, 2012. Accessed 9 October 2017.
  2. European Nutrition for Health Alliance - the Optimal Nutritional Care for All (ONCA) Campaign. Accessed 9 October 2017.
  3. de Man, F. and Eaton, D. "Optimal Nutritional Care for All." Pan European Networks: Health 01. June, 70-71 (2017). Accessed 9 October 2017.
  4. Hall, G. Editorial: "New Food Regulatory Paradigms: The Right Paths for Nutrition, Health and Disease Management," Regulatory Focus. August 2016. Regulatory Affairs Professionals Society. Accessed 9 October 2017.
  5. Commission Delegated Regulation (EU) 2016/128 of 25 September 2015 supplementing Regulation (EU) 609/2013 of the European Parliament and of the Council as regards specific compositional and information requirements for food for special medical purposes. Accessed 9 October 2017.
  6. Codex Stan 180-1991 for the Labelling of and Claims for Foods for Special Medical Purposes.
  7. Nutrition Labeling of Food, 21 CFR 101.9(j)(8). Accessed 9 October 2017.
  8. Ruthsatz, M. and Morck, T. "Medical Food/Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities." Regulatory Focus. August 2016. Regulatory Affairs Professionals Society. Accessed 9 October 2017.
  9. Ruthsatz, M. "Role of Nutritional Therapy in Healthcare Innovation: The Need for Reshaping Regulatory Paradigms." Réalités Industrielles - a series of Annales des Mines. 2017. pp.80-85. Accessed 9 October 2017.
  10. Patient Perspectives on Nutrition. By EPF, EGAN and ENHA. May 2013. Accessed 9 October 2017.
  11. European Society for Clinical Nutrition and Metabolism (ESPEN), European Union Geriatric Medicine Society (EUGMS), European Federation of National Associations of Dietitians (EFAD), European Hospital and Healthcare Federation (HOPE) and Others. Accessed 9 October 2017.
  12. Op cit 2.
  13. Op cit 3.
  14. Ljungqvist, O., van Gossum, A., Sanz, M.L. and de Man, F. "The European Fight Against Malnutrition." Clin Nutr. 2010; 29:149-50.
  15. Ljungqvist, O. and de Man, F. "Undernutrition: a Major Health Problem in Europe." Nutr Hosp. 2009; 24:369-70.
  16. Guest, J., Panca, M., Baeyens, J.P., de Man, F., Ljungqvist, O., Pichard, C., Wait, S. and Wilson, L. "Health Economic Impact of Managing Patients Following a Community-Based Diagnosis of Malnutrition in the UK." Clin Nutr. 2011.
  17. Op cit 3.
  18. European Innovation Partnership. Active and Health Ageing. Prevention of functional decline and frailty. Accessed 9 October 2017.
  19. Report of the 3rd Optimal Nutritional Care for All Conference 2016 (Madrid). Accessed 9 October 2017.
  20. Op cit 3.
  21. Toward a Renewed Patient Agenda on Nutrition for the Period 2018-2021. Conference on Medical Nutrition and Prevention for EU Patient Groups - 29 June 2017, Brussels. Accessed 9 October 2017.
  22. Manneh, I. European Survey of 907 people with cancer about the importance of nutrition. European Cancer Patient Coalition (ECPC), Brussels, 29 June 2017. Conference Presentation.
  23. Op cit 21.
  24. Op cit 3.
  25. Op cit 3.
  26. Op cit 9.
  27. Giordano-Schaefer, J., Durga, J., de Brito, F.H.X. and Schneider, H. "Medical Foods Intended to Meet Distinctive Nutrition Requirements: Scientific and Regulatory Perspective." Regulatory Focus. August 2016. Regulatory Affairs Professionals Society. Accessed 9 October 2017.
  28. European Society for Clinical Nutrition and Metabolism (ESPEN). Guidelines and Position Papers. Accessed 9 October 2017.
  29. Scientific and Technical Guidance on Foods for Special Medical Purposes in the Context of Article 3 of Regulation (EU) 609/2013. EFSA Journal. 2015; 13(11):4300 [24 pp]. Accessed 9 October 2017.
  30. Op cit 3.

About the Authors

Frank de Man, LLM, PhD, is the secretary general of the European Nutrition for Health Alliance (ENHA), London, UK. He also works for EATRIS ERIC, European Research Infrastructure for Translational Medicine, Amsterdam, NL and is responsible for governance and finance. He represented the Netherlands as Permanent Representative for health at the European Union in Brussels and Attaché for health at the NL Embassy, Washington DC, USA. He works as management consultant in Europe and the US. He may be contacted at

Cees Smit, Drhc, is policy advisor of the Patients Network for Medical Research and Health (EGAN). Since 1978, he has been member of the research project 'Haemophilia in the Netherlands' at the Leiden University Medical Centre (LUMC). From 1987 to 1998 he was coordinator of the Netherlands Haemophilia Society, from 1998 to 2002, he worked in the mental health area. He wrote several books on ageing with chronic diseases. He can be contacted at

Manfred Ruthsatz, PhD, RPh, DABT, RAC, FRAPS, is the global head regulatory advocacy at Nestlé Health Science, Epalinges, Switzerland. His healthcare regulatory experience, rounded out by quality, safety, vigilance, health economics and reimbursement, spans more than 25 years in diverse healthcare industry settings, such as US FDA's CDER and NIH. He may be contacted at

Disclaimer: this article reflects the personal opinion and experience of the authors. It should not be construed as an official position by any organization with which the authors are affiliated.

Cite as: De Man, F., Smit, C. and Ruthsatz, M. "Innovating Patient Driven Nutritonal Care Across Europe: The Optimal Nutritional Care for All (ONCA) Multistakeholder Initiative." Regulatory Focus. October 2017. Regulatory Affairs Professionals Society.


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